TissueStat TIS-003
GUDID B532TIS0030
The TissueStat Convenience Kit (TIS-003) is a class I suture deployment device that allows healthcare professionals to place a needle gently and precisely through thick, soft tissue facilitating quick placement of sutures and knot tying for tissue approximation and/or ligation.
DURASTAT LLC
Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use Suturing needle holder, single-use| Primary Device ID | B532TIS0030 |
| NIH Device Record Key | 0e0d9c8b-9c0a-4986-9d29-fa1a0fc2403a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TissueStat |
| Version Model Number | TIS-003 |
| Catalog Number | TIS-003 |
| Company DUNS | 080315253 |
| Company Name | DURASTAT LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com | |
| Phone | 8008048018 |
| CX@durastat.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B532TIS0030 [Primary] |
FDA Product Code
| HXK | Holder, Needle; Orthopedic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-26 |
| Device Publish Date | 2023-09-18 |
On-Brand Devices [TissueStat]
| B532TIS0030 | The TissueStat Convenience Kit (TIS-003) is a class I suture deployment device that allows healt |
| B532TIS0040 | TissueStat 0 PGLA Kit |
| B532TIS0010 | TissueStat 2-0 PTFE Kit |
Trademark Results [TissueStat]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TISSUESTAT 97614203 not registered Live/Pending |
DURASTAT LLC 2022-09-30 |
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